Clinical SAS Programmer - Katalyst Healthcares & Life Sciences
North Chicago, IL 60044
About the Job
Responsibilities:
Requirements:
- Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
- Generate SDTM datasets, Adam datasets, and Define.xml or Define.pdf files.
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Maintain complete and auditable documentation of all programming activities.
- Review output across SAS programs to ensure consistency.
- Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Assist Clinical Data Managers with data review via SAS programmed data checks and listings.
- Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
- Participate in the development and/or maintenance of departmental procedures and standards.
- Review CRFs, edit check specifications, and table mock-ups.
Requirements:
- You should have a bachelor's degree in Statistics, Mathematics, or in a related field, master's preferred.
- Experience has a minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer is required.
- You should have a knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
- You should be able to demonstrate extensive knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- You should possess excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- You should also possess excellent communication and interpersonal skills to effectively interface with others.
- If you have NDA submission experience that is a plus, but not required.
Source : Katalyst Healthcares & Life Sciences